(19 days)
The Vilex/DuVal Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and Tendon Reattachment. It is intended for, but not limited to. Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery.
The materials manufacture this screw are 316L, implant-quality used to stainloss steel and Ti6Al4V, implant-quality titanium. When properly with Vilex instrumentation, used this screw safe purchase and compression for cortical and achieves cancellous bone fixation in the human body.
This document is a 510(k) clearance letter from the FDA for a medical device called the "Vilex/DuVal Cannulated Bone Screw." It approves the device for marketing based on its substantial equivalence to a legally marketed predicate device.
Unfortunately, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The letter is a regulatory clearance document, not a technical report detailing performance testing or clinical studies.
Specifically, the following information is not found in the provided text:
- A table of acceptance criteria and the reported device performance: This document does not list any specific performance criteria (e.g., tensile strength, fatigue life, torque resistance) or the results of tests against such criteria.
- Sample size used for the test set and the data provenance: No information about a test set, its size, or the origin of data is present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set is described, no information about experts or ground truth establishment is available.
- Adjudication method for the test set: Not applicable as no test set is discussed.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This type of study is typically for diagnostic imaging devices involving human readers. A cannulated bone screw is an implantable surgical device, making such a study highly improbable and certainly not mentioned here.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This pertains to AI algorithms. The device in question is a physical bone screw, not an AI product.
- The type of ground truth used: No ground truth is discussed.
- The sample size for the training set: Not applicable, as this is not an AI or diagnostic imaging device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The letter primarily focuses on:
- Confirming the FDA's receipt and review of the 510(k) notification.
- Stating the substantial equivalence of the "Vilex/DuVal Cannulated Bone Screw" to pre-amendments devices or reclassified devices.
- Listing the "Indications for Use" for the device (Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment in various surgical fields).
- Specifying the materials used (316L stainless steel and Ti6Al4V titanium).
- Mentioning that the screw, when properly used with Vilex instrumentation, "achieves safe purchase and compression for cortical and cancellous bone fixation." This statement is a claim of intended function, not a quantified performance result from a specific study.
- Outlining regulatory responsibilities for the manufacturer.
To obtain the information requested, one would need to review the actual 510(k) submission (K991151 and K991197), which would contain the technical data, test reports, and details of any studies conducted to demonstrate substantial equivalence and device performance. The FDA clearance letter itself only summarizes the outcome of that review.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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APR 3 0 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Abrahim Lavi, Ph.D., M.B.A. President/CEO Vilex, Inc. 1801 Route 51 Building 10 Large, Pennsylvania 15025-0724
- K991151 and K991197 Re: Trade Name: Cannulated Screws Regulatory Class: II Product Code: HWC Dated: April 1 and 6, 1999 Received: April 6 and 8, 1999
Dear Dr. Lavi:
This letter is being issued in response to your conversation with Mr. Aric Kaise on April 28, I his letter is being issued in response to your conclosed with our letter dated April 1999, in which you stated the materials used to manufacture some of the screws 26, 1999, Inconectly deserted the materials abouts and the corrected Intended Use Aornis are described by the submissions releveled about of the mace our letter dated April 26, 1999.
enclosed and this letter is intended to supercede and replace our letter dated April
We have reviewed your Section 510(k) notification of intent to market the devices we liave leviewed your bection 910(t) is the devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that to may been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls Costicity Act (Ticl). "Toweral controls provisions of the Act include requirements for provisions of and now its ing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify the assumptions. Failure to comply with the GMP regulation may result in regulatory
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Page 2 - Abrahim Lavi, Ph.D., M.B.A.
action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not allect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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510 (k) NUMBER (IF KNOWN) : K9911A7
Vilex Cannulated Bone Screw/DuVal Cannulated Bone Screw DEVICE NAME:
INDICATIONS FOR USE:
The Vilex/DuVal Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and Tendon Reattachment. It is intended for, but not limited to. Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. The materials manufacture this screw are 316L, implant-quality used to stainloss steel and Ti6Al4V, implant-quality titanium. When properly with Vilex instrumentation, used this screw safe purchase and compression for cortical and achieves cancellous bone fixation in the human body.
(PLEASE DO NOT HRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF DACE
IF NEEDED.) IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 1991197
6.1
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.